A Randomized, Placebo-controlled, Double-blind Clinical Trial of Bacteriophage Cocktails in Chronic Wound Infections
Background
Chronic wounds are prevalent globally at endemic proportions. The common features associated with chronic wounds are prolonged inflammatory phase, infection with multidrug-resistant (MDR) bacteria, and subsequent biofilm formation. The present randomized-controlled trial (RCT) study was undertaken on chronic wounds of ≥6 weeks longer duration using customized phages to evaluate the efficacy and safety of bacteriophage therapy.
Methods
The study was conducted from December 2021 to August 2023. Thirty patients in each of the arms (placebo and bacteriophage) were recruited with chronic wounds. The patients, both arms, received the conventional treatment of wound debridement, local antiseptics, and local and systemic antibiotics at the discretion of the treating surgeon. However, before applying the customized bacteriophage cocktail or placebo, the wound surface was thoroughly washed to remove the residual antiseptics. The phage cocktails or placebo were applied on alternate days. The wounds were evaluated using the Bates-Jensen Wound Assessment Tool for the progress of wound healing.
Results
A total of 93.3% of the wound became sterile in 39 days (median sterility time), followed by complete healing by the end of 90 days in the phage group. Contrary to this, 83.3% of those on placebo therapy remained colonized by original bacteria or additional new bacteria without healing for up to 90 days.
Conclusion
With the well-designed RCT, we could conclude that customized bacteriophage therapy using bacteriophage cocktails will definitely cure the chronic wound, irrespective of age, sex, diabetes status, and infection by MDR bacteria.
Top-30
Journals
|
1
2
|
|
|
Frontiers in Cellular and Infection Microbiology
2 publications, 11.76%
|
|
|
Journal of Oral Microbiology
1 publication, 5.88%
|
|
|
Brazilian Journal of Microbiology
1 publication, 5.88%
|
|
|
International Orthopaedics
1 publication, 5.88%
|
|
|
Annals of the New York Academy of Sciences
1 publication, 5.88%
|
|
|
Archives of Microbiology
1 publication, 5.88%
|
|
|
Infectious Disease Reports
1 publication, 5.88%
|
|
|
Drugs and Drug Candidates
1 publication, 5.88%
|
|
|
Reviews in Medical Microbiology
1 publication, 5.88%
|
|
|
Frontiers in Microbiology
1 publication, 5.88%
|
|
|
Journal of Applied Microbiology
1 publication, 5.88%
|
|
|
International Journal of Antimicrobial Agents
1 publication, 5.88%
|
|
|
Journal of Dentistry
1 publication, 5.88%
|
|
|
Therapeutic Advances in Infectious Disease
1 publication, 5.88%
|
|
|
Chinese Medical Journal
1 publication, 5.88%
|
|
|
Biomaterials Advances
1 publication, 5.88%
|
|
|
1
2
|
Publishers
|
1
2
3
|
|
|
Springer Nature
3 publications, 17.65%
|
|
|
Frontiers Media S.A.
3 publications, 17.65%
|
|
|
Elsevier
3 publications, 17.65%
|
|
|
MDPI
2 publications, 11.76%
|
|
|
Ovid Technologies (Wolters Kluwer Health)
2 publications, 11.76%
|
|
|
Taylor & Francis
1 publication, 5.88%
|
|
|
Wiley
1 publication, 5.88%
|
|
|
Oxford University Press
1 publication, 5.88%
|
|
|
SAGE
1 publication, 5.88%
|
|
|
1
2
3
|
- We do not take into account publications without a DOI.
- Statistics recalculated weekly.